PROTECTION DEVICE FOR PROTECTING AN INJECTION NEEDLE

Description

[0001] The present invention relates to a protection device for protecting a needle so as to protect the patient and/or the user from the risk of needlestick injury, particularly after the said needle has been used.

[0002] In the medical field, syringes may be supplied ready for use or in the form of kits to be assembled, which may or may not be pre-filled with the liquid that is to be injected. Thus, the liquid that is to be injected is often supplied within a syringe body containing the dose that is to be injected. The end of the syringe body may be provided directly with a needle or may be provided with a syringe tip to which a needle support bearing the needle can be fixed. This syringe tip is, for example, of the "luer" or "luer lock" type. These syringes, syringe tips and needle supports are preferably "single-use" items so as to limit the risk of contaminating the patients and/or the care personnel with equipment that has already been used.

[0003] In this field, it is also of prime importance that the patients and users be protected from any risk of needlestick injury, particularly between the moment that injection is finished and the discarding of the injection device. Sleeves that protect the needles and that are activated manually after injection exist but in order to render the operation of protecting the needle more reliable and easier for the user, attempts have been made to render automatic the placement of the protective sleeve around the needle at the moment the needle is withdrawn from the injection site.

[0004] Document EP 409 180 describes a device for protecting a needle comprising a moving sleeve intended to cover the needle after injection. However, this protection device entails the sleeve rotating on itself by a certain amount in order to trigger its deployment, this rotation being performed while the distal end of the sleeve is in contact with the patient's skin, and while the medicinal product is being injected.

[0005] Thus, in such a case, because of the rotating of the sleeve, an undesirable feeling of friction against the skin and/or of instability of the injection device is perceived by the patient and/or by the user. This results in a notable impediment to the giving of the injection. As the injection cannot then be administered under optimal conditions, the patient and/or the user are reluctant to use the safety devices concerned and this often causes them to put themselves in unsafe injecting conditions. This solution is therefore not satisfactory.

[0006] Documents US2003/093035 and WO91/11212 disclose injection devices comprising a sleeve that rotates with respect to a support when moving from an injection position to a protection position.

[0007] Document US2002/004652 discloses an injection device comprising protection means of the needle after the device is used.

[0008] Document US2002/0004648 discloses a needle hub bearing a disposable double pointed injection needle, the needle hub being provided with a movable needle protection means.

[0009] Document US2004/02300158 discloses an injection device comprising a needle assembly, the injection device being provided with a shield coaxially received over the needle assembly.

[0010] There therefore remains a need for a device for protecting a needle, without additional manual intervention on the part of the user and which does not give rise to an effect of friction against the patient's skin.

[0011] The present invention aims to satisfy this need by proposing a device for protecting a needle that is effective, reliable whith safety operation not directly linked to friction specificities, easy to manufacture and to use, comprises a limited number of parts, can be activated after injection without additional manual intervention on the part of the user so as to cover the needle, the said needle protection device not giving rise to any effect of friction against the patient's skin and limiting the risks of needlestick injury. In order to increase the safety of the injection, the present invention is also aimed at proposing such a needle protection device that is irreversible, preventing access to the needle once it has been activated. The present invention is also aimed at proposing a needle protection device that can be used in any field of medicine, veterinary science and with any injection device such as, for example, syringes, catheters and any other equivalent device.

[0012] The present invention relates to a protection device intended to at least partially cover the needle of an injection device, the said protection device comprising at least:

• a support provided with fixing means intended to secure the said protection device to an injection device,
• a sleeve comprising a distal end intended to come into contact with an injection surface and provided with an orifice intended to allow the said needle to pass, the said sleeve being arranged in such a way as to be moveable axially in translation with respect to the said support from a first position known as the storage position, in which the distal end of the said sleeve is at a distance 11 from the said fixing means, to a second position known as the injection position, in which the distal end of the said sleeve is at a distance 12 from the said fixing means, and to a third position known as the protection position, in which the distal end of the said sleeve is at a distance 13 from the said fixing means, the said distances 11 and 13 being greater than the said distance 12,
• first return means for returning the said sleeve at least from its injection position to its protection position,
• at least one peg, directly and at least elastically, coupled longitudinally to the said support or to the said sleeve and housed in a running passageway provided respectively in the said sleeve or in the said support, the said running passageway forming more or less a U, of which the branches respectively define a first section taken by the said peg as the said sleeve moves from its storage position to its injection position and a second section taken by the said peg as the said sleeve passes from its injection position to its protection position, the said peg being designed to be laterally mobile,
• first safety means, at least part of them being elastically deformable, said first safety means being arranged in such a way as to prevent the said peg from returning from the said second section to the said first section,

characterized in that the said protection device comprises at least:

• axial guidance means for guiding the said sleeve, arranged in such a way as to prevent it from pivoting axially as it moves axially with respect to the said support at least from its injection position to its protection position.

[0013] The protection device according to the invention is able to protect efficiently the needle of an injection device, at least after injection., Particularly by virtue of the presence of a peg that can move laterally and which is longitudinally linked to the support, the impact of friction problem due to moving parts and that is encountered in other prior art protection devices, is avoided. Therefore, the protection device according to the invention is a more reliable protection device.

[0014] Furthermore, because the sleeve of the device according to the invention does not rotate on itself during the entire operation of administering the medicinal product, the injection is at no time disrupted by the effect of friction against the patient's skin, it is therefore easier and safer and can be administered without inconveniencing either of the patient or the user.

[0015] In addition, the protection device according to the invention makes it possible to avoid the risks of needlestick injury after injection as the needle is withdrawn from the injection site. What happens, after injection, as the injection device is withdrawn, is that the return means allow deployment of the sleeve without the user having to perform any additional manual operation. The operation of triggering the placement of the sleeve is therefore also safe.

[0016] The present invention also relates to an injection device comprising a needle protection device described hereinabove.

[0017] By virtue of the features of the invention, it is possible to supply an injection device ready for use and provided with the said protection device, it being possible for the end of the needle of the injection device to be visible, but nonetheless safe. Indeed, it may be important to nurses to have an injection device in which the end of the needle is visible: that allows them to expel air prior to most injections, with the best possible view of what they are doing. That also allows them better control over the first phase of the operation of injecting the medicinal product, namely the phase of positioning the needle on the injection site and orientating the tip of the needle with a view to inserting it and injecting the medicinal product.

[0018] In this application, the distal end of a component or a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the "distal direction" is to be understood as meaning the direction of injection, and the "proximal direction" is to be understood as meaning the opposite direction to the direction of injection.

[0019] Within the meaning of this application, the "injection surface" may be the patient's skin in the case of an injection, the membrane of a bottle from which the product is taken or in which it is mixed, the end of a tube, of a pipe, the wall of a flexible bag, or of any connecting means.

[0020] The expression "able to move laterally" is to be understood, within the context of the current application, as meaning that the peg can move in a rectilinear or linear fashion in a plane perpendicular to the axis of the device, or in a circular fashion in a plane parallel to the axis of the device.

[0021] As a preference, the said axial-guidance means are arranged in such a way as also to prevent the said sleeve from pivoting axially as it moves axially with respect to the said support from its storage position to its injection position.

[0022] Advantageously, the said axial-guidance means comprise more or less complementary longitudinal geometric shapes provided respectively on the said sleeve and on the said support and arranged facing one another in order to collaborate. These geometric shapes may be grooves, ribs, bulges or alternatively slideways.

[0023] As a preference, the said first and second sections of the said running passageway are joined together by a first narrowed region defined by a flexible tongue at least partially defining the said first safety means.

[0024] Advantageously, the peg may be solid and made of a deformable material; it may be hollow, its walls deforming inwards, or may be formed of flexible tabs.

[0025] Advantageously, the said peg is urged laterally from the said first section towards the said second section by second return means at least partially defining the said first safety means.

[0026] As a preference, the said support or, respectively, the said sleeve comprises at least one tab able to deflect tangentially and bearing the said peg. Advantageously, the said tab is arranged in such a way as to deflect tangentially in an elastically deformable manner between a normal position and at least one stressed deflected position, said tab at least partially defining the said first safety means..

[0027] For example, the said tab is in a normal position or, respectively, in a stressed deflected position when the said peg is in the said first section, and the said tab is in the stressed deflected position or, respectively, in the normal position when the said peg is in the said second section. The said tab may be made of an elastically deformable material. The said tab may also comprise a pivot connection or a ball joint, which is elastically deformable, it being possible for this connection to be coupled to these return means.

[0028] As a preference, the said first and second sections have different lengths arranged in such a way as to delimit the said storage and protection positions such that the said distance 13 is greater than the said distance 11.

[0029] As a preference, facing the said running passageway provided on the said sleeve or, respectively, on the said support, the said support or, respectively, the said sleeve comprises a deflection passage arranged in such a way as to guide the said peg laterally.

[0030] In one embodiment of the invention, the said protection device comprises second safety means arranged in such a way as to block the said peg when the said sleeve is in the said protection position.

[0031] As a preference, the said second section of the said running passageway comprises a second narrowed region at least partially defining the said second safety means.

[0032] Advantageously, the said second section of the said running passageway comprises at least one step forming a stop catch for the said peg when the said sleeve is in the said protection position and at least partially defining the said second safety means.

[0033] In one embodiment of the invention, the said running passageway and/or the said deflection passage is formed of at least one element chosen from the group comprising a groove, a slot, a rib or a combination of these elements.

[0034] Advantageously, the said first and/or second return means are elastically deformable and chosen from the group comprising a helical spring, an elastic leaf, an elastically deformable element.

[0035] As a preference, the said first return means are arranged between the proximal end of the said support and the distal end of the said sleeve.

[0036] As a preference, the said sleeve or, respectively, the said support comprises at least one stop wall situated facing the said tab when the device is in the protection position, the said stop wall being arranged in such a way as to prevent the radial deflection of the said tab towards the axis of the said protection device in this protection position.

[0037] As a preference, the said support is provided with an injection needle.

[0038] The present invention also relates to an injection device comprising at least one injection needle and a reservoir of product that is to be injected, characterized in that it comprises at least one protection device as described hereinabove.

[0039] The present invention also relates to a set comprising a device as described hereinabove and packaging for this device, the said packaging comprising a cylindrical body and a cap, the said cylindrical body being equipped on its internal wall with means for blocking the rotation and translation of the said device within the said packaging.

[0040] The present invention will now be described in greater detail with the aid of the attached drawings in which:

• Figure 1 is an exploded perspective view of the protection device according to the invention and of an end of a syringe body,
• Figures 2 and 5 are, respectively, a side view and a view in section of the protection device of Figure 1 in the storage position and of the end of an injection device,
• Figure 3 is a side view of the protection device of Figure 1, in the injection position,
• Figure 4 is a side view of the protection device of Figure 1 in the protection position,
• Figure 6 is an exploded perspective view of packaging for the protection device of Figure 1,
• Figures 7 to 8 are side views of a second alternative form of embodiment of the protection device according to the invention in the storage position, the injection position and the protection position respectively,
• Figures 10 to 13 are side views of a third alternative form of embodiment of the protection device according to the invention in the storage position, the start-of-injection position, the end-of-injection position and the protection position, respectively,
• Figure 14 is a partial sectioned view of the running passageway of the alternative form of embodiment of Figures 10 to 13.

[0041] Figure 1 depicts a protection device 1 for protecting an injection needle 2 according to the invention. This protection device 1 comprises a support 3 for a needle 2 and a sleeve 4 arranged in such a way as to accept the support 3. This sleeve 4 can be moved in translation with respect to the support 3, from a storage position depicted in Figure 2 towards a second position, the injection position, depicted in Figure 3 and towards a third position, the protection position, depicted in Figure 4.

[0042] In the example depicted, the support 3 and the sleeve 4 each comprise means for the guidance and axial translation of the support 3 with respect to the sleeve 4: in Figure 1, these guide means are in the form of diametrically opposed longitudinal bulges 29 situated on the external wall of the support 3, these longitudinal bulges 29 collaborating with diametrically opposed slideways 30 situated on the internal wall of the sleeve 4, facing the said bulges 29.

[0043] In Figure 1, the support 3 comprises a flexible tab 5 which runs longitudinally from the proximal part of the support 3 in the distal direction. This flexible tab 5 at its distal end comprises a peg 6. This flexible tab 5 is able to deflect laterally between a normal position and at least one stressed deflected position (see Figure 4). In Figure 1, this flexible tab 5 is depicted in its normal position. Still in this figure, the tab 5 is able to move from its normal position to its stressed deflected position within a window 7 cut into the wall of the support 3. The support 3 comprises a stop wall 8 partially closing off the window 7, the function of which will be explained later on.

[0044] In Figure 1, the support 3 comprises two proximal fins 9. These fins 9 may serve to block the rotation and translation of the device of the invention within its packaging (see Figure 6) or to lock it in a standard "luer lock" connection system.

[0045] In the example depicted, the sleeve 4 comprises a running passageway 10 forming a U, made in the wall of the sleeve 4 and arranged in such a way as to collaborate with the peg 6 over the entire travel of the sleeve, as will be apparent from Figures 2-4.

[0046] As can also be seen in Figures 2-4, the running passageway 10 comprises a first longitudinal section 11 and a second longitudinal section 12, which are more or less parallel and slightly angularly offset from one another about the longitudinal axis of the device 1. These two longitudinal sections 11 and 12 are connected to one another at their respective distal ends by an intermediate section 13.

[0047] As depicted in Figure 1, the protection device 1 also comprises a helical spring 14. When the device 1 is assembled, as can be seen in Figure 5, the proximal end 31 of this helical device 14 bears against an internal flange 32 of the proximal part of the support 3 and the distal end 33 of the spring 14 bears against the internal face of the radial distal wall 15 of the sleeve 4.

[0048] The way in which the protection device 1 according to the invention works will now be described with reference to Figures 2-4.

[0049] With reference to Figures 2 and 5, the protection device 1 is in the storage position. The sleeve 4 partially covers the needle 2. Thus, part of the needle 2 is visible for better user control both of the expelling of air and of the phase of positioning the needle 2 on the injection site prior to penetration.

[0050] In this storage position, the flexible tab 5 (partly concealed by the sleeve 4 in Figure 2) is in the normal position and the peg 6 is kept in abutment against the proximal end 16 of the first longitudinal section 11 of the running passageway 10 by the action of the spring 14 which is partially compressed between the sleeve 4 and the support 3, as can be seen in Figure 5.

[0051] The protection device 1 is therefore supplied for use in this storage position. The user then equips himself with the syringe body 17, partially depicted in Figure 2, prefilled with the medicinal product to be injected into the injection site. This syringe body 17 comprises a standard distal tip 18 that can be fitted to the proximal base 19 (see Figure 1) of the support 3 for connection to the needle 2. The user thus connects the syringe body 17 to the protection device 1 of the invention. For simplicity, the syringe body 17 will not be depicted in Figures 3 and 4.

[0052] Once the syringe body 17 is connected to the protection device 1, the user begins to cause the needle 2 to penetrate the injection site, until the distal radial wall 15 of the sleeve 4 comes into contact with the surface of the injection site and then he continues, via the syringe 17, to press on the support 3 in order to ensure complete penetration of the needle 2 in the injection site, the distal radial wall 15 of the sleeve 4 still being in contact with the surface of the injection site. The sleeve 4 therefore moves proximally in the axial direction with respect to the support 3 until the radial peg 6, which takes the path of the first longitudinal section 11, comes into abutment against the distal end 20 of this first longitudinal section 11.

[0053] The protection device 1 is then in the injection position as depicted in Figure 3. In such a position, the spring 14 is in the compressed state and the needle 2 is exposed, that is to say not covered by the sleeve 4 because it is inside the injection site.

[0054] During the move from the storage position to the injection position, the sleeve 4 has not rotated on itself. The user then proceeds with injecting the medicinal product from the syringe body 17 in the known way, maintaining his pressure on the support 3, and the protection device 1 thus remains in the position depicted in Figure 3.

[0055] At the end of injection, the user releases the pressure he was exerting on the support 3 via the syringe and proceeds to withdraw the needle 2 from the injection site, thus releasing the spring 14 which returns to its relaxed position carrying with it the support 3 which completely covers the needle 2. The flexible tab 5 and its radial peg 6 then take the path marked out by the intermediate section 13 and the second longitudinal section 12 of the running passageway 10, as shown in Figure 4.

[0056] As can be seen in Figures 2-4, the first longitudinal section 11 comprises, situated proximally at its distal end 20, a narrowing 21 defined by a flexible tongue 39 which allows the peg 6 to pass in the distal direction and prevents the said peg 6 from returning in the proximal direction. In this embodiment, the flexible tongue 39 forms at least in part the first safety means, elastically deformable, preventing the peg 6 from returning from the said second section 12 to the said first section 11.

[0057] As the sleeve 4 deploys, when the peg 6 can follow the path marked out by the intermediate section 13 and the second longitudinal section 12 of the running passageway 10 by virtue of the ability of the tab 5 to deflect tangentially under stress.

[0058] For preference, the flexible tab 5 is made of a deformable and semi-rigid material such as polypropylene.

[0059] Thus, in the protection position as depicted in Figure 4, the flexible tab 5 is in a stressed deflected position and the peg 6 is kept bearing against the proximal end 22 of the second longitudinal section 13 by the action of the spring 14 which is then in the at least partially relaxed position.

[0060] In order to block the protection device 1 in the protection position, the second longitudinal section 12 of the running passageway 10 comprises, situated distally at its proximal end 22, a narrowing 23 which allows the peg 6 to pass in the proximal direction and prevents the said peg 6 from returning in the distal direction. As a preference, the peg 6 or the narrowing 23 is able to deform elastically to allow this passing. There is thus no risk of the needle 2 re-emerging from the sleeve 4. In the example depicted, this narrowing 23 is obtained by the presence of two steps 24 and 25 situated facing one another on the second longitudinal section 12.

[0061] In the protection position, as depicted in Figure 4, the peg 6 faces the stop wall 8 formed in the window 7 of the support 3. This stop wall 8 prevents the flexible tab 5 from deflecting radially towards the inside of the support: thus, it is not possible to separate the sleeve 4 from the support 3 and to reexpose the needle 2.

[0062] In an embodiment, not depicted, the second longitudinal section 12 of the running passageway 10 comprises a clearance space which is directed towards the first longitudinal section 11 and in which the peg 6 becomes blocked in a protection position in which the flexible tab 5 is partly or completely deflected.

[0063] In another undepicted embodiment of the invention, the flexible tab 5 is arranged on the sleeve 4 and the running passageway 10 is formed within the wall of the support 3. In yet another embodiment, not depicted, the flexible tab 5 is in a stressed deflected position when the protection device 1 is in the storage position and is in its normal position when the protection device 1 is in the protection position. In this embodiment, the flexible tab 5 forms at least in part the first safety means, elastically deformable, preventing the peg 6 from returning from the said second section 12 to the said first section 11.

[0064] In another embodiment of the invention, not depicted, the sleeve is inside the support.

[0065] Figure 6 depicts packaging 26 for the device 1 of the invention. Specifically, as the needle 2 is partially exposed when the protection device 1 is in the storage position, it is preferable for it to be supplied in protective packaging. The packaging 26 of Figure 5 comprises a cylindrical body 27 and a cap 28. As a preference, the body 27 comprises, on its internal cylindrical wall, striations which collaborate with the fins 9 of the support 3 to prevent the device 1 from rotating within the packaging 26.

[0066] The protection device 1 of Figure 7 to 9 is similar to the device of Figures 1 to 6. It differs therefrom in that the running passageway 10 (depicted in dotted line in Figures 7 and 8 and partially in solid line in Figure 9) is situated on the said support 3 and in that the flexible tab is replaced by a pivoting tab 31 equipped with a pivot connection 32, situated on the sleeve 4. The pivoting of the pivoting tab 31 occurs within a window 33 of triangular overall shape formed in the wall of the sleeve 4. The running passageway 10 is U-shaped, the second longitudinal section 12 of the U being longer than the first longitudinal section 11. Thus, the distance 13 is greater than the distance 11. The branches of the U are separated by a flexible tongue 39.

[0067] In the storage position, as depicted in Figure 7, the peg 6 of the pivoting tab 31 is blocked in the distal end of the first longitudinal section 11 of the U forming the running passageway 10. Between the storage position and the injection position, the peg 6 is displaced along the first longitudinal section 11 where it presses against the flexible tongue 39 and bends it to reach the vertex 36 of the U. The flexible tongue 39 prevents the peg 6 from coming back to its storage position and forms at least part of the first safety means. In the injection position, as depicted in Figure 8, the pivoting tab 31 has pivoted and the peg 6 is blocked in the vertex 36 of the U that forms the running passageway 10. In the protection position, as depicted in Figure 9, the pivoting tab 31 has continued to pivot about the pivot connection 32 and the peg 6 is blocked in the second longitudinal section 12 of the U that forms the running passageway 10 by a narrowed region, not depicted.

[0068] In an undepicted embodiment of the invention, the pivoting tab does not move in a window; only the peg moves in a deflection passage.

[0069] In yet another undepicted embodiment of the invention, the sleeve has no window and the tab is superposed on the inside of the wall of the sleeve: thus neither the tab nor the peg move in a window.

[0070] The protection device 1 of Figures 10 to 14 is similar to the protection device of Figures 1 to 6. It differs therefrom in that the peg 6 is subject to the action of a spring 34 which is urged laterally from the first longitudinal section 11 towards the second longitudinal section 12 of the running passageway 10. The support 3 comprises a deflection passage 35 arranged in such a way as to guide the said peg 6 laterally.

[0071] Thus, in the storage position, as depicted in Figures 10 and 14, the peg 6 is blocked against the proximal end of the first longitudinal section 11 of the running passageway 10 because of the thrust of the spring 34 which is in the compressed state.

[0072] In the start-of-injection position, as depicted in Figure 11, the peg 6 arrives in the deflection passage 35 in which it is pushed by the spring 34 which relaxes. In this embodiment, the spring 34 forms at least in part the first safety means, elastically deformable, preventing the peg 6 from returning from the said second section 12 to the said first section 11.

[0073] Thus, when the user withdraws the injection device 1 from the injection site, the peg 6 is guided in the second longitudinal section 12 of the running passageway 10. In the protection position, as depicted in Figure 13, the peg 6 is kept blocked against the proximal end 38 of the second longitudinal section 12 of the running passageway 10 by the thrust of the spring 34. The needle is perfectly covered by the sleeve. The injection device 1 is safe.

[0074] As is apparent from the above description, the protection device 1 according to the invention allows an injection to be given in complete safety by virtue in particular of the fact that the sleeve 4 that protects the needle 2 does not rotate on itself at any time during the injection process and by virtue of the fact that this sleeve 4 deploys automatically at the end of the injection without any additional manual operation on the part of the user. In addition, the reliability of the protection device 1 according to the invention is increased by the reduced number of parts involved and their reduced relative movement with therefore enable to limit problems due to friction between moving parts.

Claims

1. Protection device (1) intended to at least partially cover the needle (2) of an injection device, the said protection device (1) comprising at least:

- a support (3) provided with fixing means (9) intended to secure the said protection device (1) to an injection device,

- a sleeve (4) comprising a distal end (15) intended to come into contact with an injection surface and provided with an orifice intended to allow the said needle to pass, the said sleeve (4) being arranged in such a way as to be moveable axially in translation with respect to the said support (3) from a first position known as the storage position, in which the distal end of the said sleeve (4) is at a distance 11 from the said fixing means, to a second position known as the injection position, in which the distal end of the said sleeve (4) is at a distance 12 from the said fixing means, and to a third position known as the protection position, in which the distal end of the said sleeve (4) is at a distance 13 from the said fixing means, the said distances 11 and 13 being greater than the said distance 12,

- first return means (14) for returning the said sleeve (4) at least from its injection position to its protection position,

- at least one peg (6), directly and at least elastically, coupled longitudinally to the said support (3) or to the said sleeve (4) and housed in a running passageway (10) provided respectively in the said sleeve (4) or in the said support (3), the said running passageway (10) forming more or less a U, of which the branches respectively define a first section (11) taken by the said peg (6) as the said sleeve (4) moves from its storage position to its injection position and a second section (12) taken by the said peg (6) as the said sleeve (4) passes from its injection position to its protection position, the said peg (6) being designed to be laterally mobile,

- first safety means (5, 21; 39, 34, 35), at least part of them being elastically deformable, said first safety means (5, 21; 39, 36, 34, 35) being arranged in such a way as to prevent the said peg (6) from returning from the said second section (12) to the said first section (11),

characterized in that the said protection device (1) comprises at least:

- axial guidance means (29, 30) for guiding the said sleeve (4), arranged in such a way as to prevent it from pivoting axially as it moves axially with respect to the said support (3) at least from its injection position to its protection position.

2. Protection device (1) according to Claim 1, characterized in that the said axial-guidance means (29, 30) are arranged in such a way as also to prevent the said sleeve (4) from pivoting axially as it moves axially with respect to the said support (3) from its storage position to its injection position.

3. Protection device (1) according to Claim 1, characterized in that the said axial-guidance means (29, 30) comprise more or less complementary longitudinal geometric shapes provided respectively on the said sleeve (4) and on the said support (3) and arranged facing one another in order to collaborate.

4. Protection device (1) according to Claim 1, characterized in that the said first and second sections (11, 12) of the said running passageway (10) are joined together by a first narrowed region (21, 36) defined by a flexible tongue (39) at least partially defining the said first safety means.

5. Protection device (1) according to Claim 1, characterized in that the said peg (6) is urged laterally from the said first section towards the said second section by second return means (34) at least partially defining the said first safety means.

6. Protection device (1) according to Claim 1, characterized in that the said support (3) or, respectively, the said sleeve (4) comprises at least one tab (5) able to deflect tangentially and bearing the said peg (6).

7. Protection device (1) according to Claim 6, characterized in that the said tab is arranged in such a way as to deflect tangentially in an elastically deformable manner between a normal position and at least one stressed deflected position, said tab (5) at least partially defining the said first safety means.

8. Protection device (1) according to Claim 7, characterized in that the said tab (5) is in a normal position or, respectively, in a stressed deflected position when the said peg (6) is in the said first section (11), and the said tab (5) is in the stressed deflected position or, respectively, in the normal position when the said peg (6) is in the said second section (12).

9. Protection device (1) according to Claim 1, characterized in that the said first and second sections (11, 12) have different lengths arranged in such a way as to delimit the said storage and protection positions such that the said distance 13 is greater than the said distance 11.

10. Protection device (1) according to Claim 1, characterized in that, facing the said running passageway (10) provided on the said sleeve (4) or, respectively, on the said support (3), the said support (3) or, respectively, the said sleeve (4) comprises a deflection passage (35) arranged in such a way as to guide the said peg (6) laterally.

11. Protection device (1) according to Claim 1, characterized in that it comprises second safety means (23, 33, 37, 34, 38) arranged in such a way as to block the said peg (6) when the said sleeve (4) is in the said protection position.

12. Protection device (1) according to Claim 11, characterized in that the said second section (12) of the said running passageway (10) comprises a second narrowed region (23) at least partially defining the said second safety means.

13. Protection device (1) according to Claim 11, characterized in that the said second section (12) of the said running passageway (10) comprises at least one step (24) forming a stop catch for the said peg (6) when the said sleeve (4) is in the said protection position and at least partially defining the said second safety means.

14. Protection device (1) according to Claim 1 or 10, characterized in that the said running passageway (10) and/or the said deflection passage (35) is formed of at least one element chosen from the group comprising a groove, a slot, a rib or a combination of these elements.

15. Protection device (1) according to Claim 1 or 5, characterized in that the said first and/or second return means (14, 34) are elastically deformable and chosen from the group comprising a helical spring, an elastic leaf, an elastically deformable element.

16. Protection device (1) according to Claim 1, characterized in that the said first return means (14) are arranged between the proximal end of the said support (3) and the distal end of the said sleeve (4).

17. Protection device (1) according to Claim 6, characterized in that the said sleeve (4) or, respectively, the said support (3) comprises at least one stop wall (8) situated facing the said tab (5) when the device (1) is in the protection position, the said stop wall (8) being arranged in such a way as to prevent the radial deflection of the said tab (5) towards the axis of the said protection device in this protection position.

18. Protection device (1) according to Claim 1, characterized in that the said support (3) is provided with an injection needle (2).

19. Injection device (1) comprising at least one injection needle (2) and a reservoir of product that is to be injected, characterized in that it comprises at least one protection device (1) according to at least one of Claims 1 to 18.

20. Set comprising a protection device (1) according to any one of Claims 1 to 18 and packaging (26) for this device, the said packaging comprising a cylindrical body (27) and a cap (28), the said cylindrical body being equipped on its internal wall with means for blocking the rotation and translation of the said device within the said packaging.

Ansprüche

1. Schutzvorrichtung (1), die ausgelegt ist, um mindestens teilweise die Nadel (2) einer Injektionsvorrichtung abzudecken, wobei die Schutzvorrichtung (1) mindestens Folgendes umfasst:

- einen Träger (3), der mit Fixierungsmitteln (9) bereitgestellt ist, die ausgelegt sind, um die Schutzvorrichtung (1) an eine Injektionsvorrichtung zu befestigen,

- eine Hülse (4), umfassend ein distales Ende (15), das ausgelegt ist, um mit einer Injektionsoberfläche in Kontakt zu kommen, und mit einer Öffnung bereitgestellt ist, die ausgelegt ist, um der Nadel zu ermöglichen, zu passieren, wobei die Hülse (4) derart angeordnet ist, dass sie sich axial in Translation mit Bezug auf den Träger (3) aus einer ersten Position, bezeichnet als Speicherposition, in der das distale Ende der Hülse (4) in einem Abstand l1 von den Fixierungsmitteln ist, in eine zweite Position, bezeichnet als Injektionsposition, in der das distale Ende der Hülse (4) in einem Abstand l2 von den Fixierungsmitteln ist, und in eine dritte Position, bezeichnet als Schutzposition, bewegen kann, in der das distale Ende der Hülse (4) in einem Abstand l3 von den Fixierungsmitteln ist, wobei die Abstände l1 und l3 größer als der Abstand l2 sind,

- erste Rückstellmittel (14), um die Hülse (4) mindestens aus ihrer Injektionsposition in ihre Schutzposition rückzustellen,

- mindestens einen Zapfen (6), der direkt und mindestens elastisch längs an den Träger (3) oder an die Hülse (4) gekoppelt und in einem Laufdurchgang (10) aufgenommen ist, der jeweils in der Hülse (4) oder in dem Träger (3) bereitgestellt ist, wobei der Laufdurchgang (10) mehr oder weniger ein U bildet, dessen Schenkel jeweils einen ersten Abschnitt (11), besetzt durch den Zapfen (6), wenn sich die Hülse (4) von ihrer Speicherposition in ihre Injektionsposition bewegt, und einen zweiten Abschnitt (12), besetzt durch den Zapfen (6), wenn die Hülse (4) aus ihrer Injektionsposition in ihre Schutzposition übergeht, definieren, wobei der Zapfen (6) entworfen ist, um lateral beweglich zu sein,

- erste Sicherheitsmittel (5, 21; 39, 34, 35), von denen mindestens ein Teil elastisch verformbar ist, wobei die ersten Sicherheitsmittel (5, 21; 39, 36, 34, 35) derart angeordnet sind, dass sie verhindern, dass der Zapfen (6) aus dem zweiten Abschnitt (12) in den ersten Abschnitt (11) rückgestellt wird,

dadurch gekennzeichnet, dass die Schutzvorrichtung (1) mindestens Folgendes umfasst:

- axiale Führungsmittel (29, 30), um die Hülse (4) zu führen, die derart angeordnet sind, dass sie verhindern, dass sie axial schwankt, wenn sie sich axial mit Bezug auf den Träger (3) mindestens aus ihrer Injektionsposition in ihre Schutzposition bewegt.

2. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass die axialen Führungsmittel (29, 30) derart angeordnet sind, dass sie auch verhindern, dass die Hülse (4) axial schwankt, wenn sie sich axial mit Bezug auf den Träger (3) aus ihrer Speicherposition in ihre Injektionsposition bewegt.

3. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass die axialen Führungsmittel (29, 30) mehr oder weniger komplementäre längs gerichtete geometrische Formen umfassen, die jeweils auf der Hülse (4) und auf dem Träger (3) bereitgestellt und einander gegenüber angeordnet sind, um zusammenzuarbeiten.

4. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass der erste und zweite Abschnitt (11, 12) des Laufdurchgangs (10) durch einen ersten verengten Bereich (21, 36) miteinander verbunden sind, der durch eine flexible Zunge (39) definiert ist, die mindestens teilweise das erste Sicherheitsmittel definiert.

5. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass der Zapfen (6) lateral von dem ersten Abschnitt hin zu dem zweiten Abschnitt durch zweite Rückstellmittel (34) gezwungen wird, die mindestens teilweise das erste Sicherheitsmittel definieren.

6. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass der Träger (3) bzw. die Hülse (4) mindestens eine Lasche (5) umfasst, die dazu in der Lage ist, sich tangential zu biegen und den Zapfen (6) zu tragen.

7. Schutzvorrichtung (1) nach Anspruch 6, dadurch gekennzeichnet, dass die Lasche derart angeordnet ist, dass sie sich tangential auf eine elastisch verformbare Weise zwischen einer normalen Position und mindestens einer gespannten gebogenen Position biegt, wobei die Lasche (5) mindestens teilweise das erste Sicherheitsmittel definiert.

8. Schutzvorrichtung (1) nach Anspruch 7, dadurch gekennzeichnet, dass die Lasche (5) in einer normalen Position bzw. in einer gespannten gebogenen Position ist, wenn der Zapfen (6) in dem ersten Abschnitt (11) ist, und die Lasche (5) in der gespannten gebogenen Position bzw. in der normalen Position ist, wenn der Zapfen (6) im zweiten Abschnitt (12) ist.

9. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass der erste und der zweite Abschnitt (11, 12) verschiedene Längen aufweisen, die derart angeordnet sind, dass sie die Speicher- und Schutzposition derart begrenzen, dass der Abstand l3 größer als der Abstand l1 ist.

10. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass gegenüber dem Laufdurchgang (10), bereitgestellt auf der Hülse (4) bzw. auf dem Träger (3), der Träger (3) bzw. die Hülse (4) einen Biegungsdurchgang (35) umfasst, der derart angeordnet ist, dass er den Zapfen (6) lateral führt.

11. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass sie zweite Sicherheitsmittel (23, 33, 37, 34, 38) umfasst, die derart angeordnet sind, dass sie dem Zapfen (6) blockieren, wenn die Hülse (4) in der Schutzposition ist.

12. Schutzvorrichtung (1) nach Anspruch 11, dadurch gekennzeichnet, dass der zweite Abschnitt (12) des Laufdurchgangs (10) einen zweiten verengten Bereich (23) umfasst, der mindestens teilweise die zweiten Sicherheitsmittel definiert.

13. Schutzvorrichtung (1) nach Anspruch 11, dadurch gekennzeichnet, dass der zweite Abschnitt (12) des Laufdurchgangs (10) mindestens einen Absatz (24) umfasst, der eine Sperrklinke für den Zapfen (6) bildet, wenn die Hülse (4) in der Schutzposition ist, die mindestens teilweise die zweiten Sicherheitsmittel definiert.

14. Schutzvorrichtung (1) nach Anspruch 1 oder 10, dadurch gekennzeichnet, dass der Laufdurchgang (10) und/oder der Biegungsdurchgang (35) aus mindestens einem Element gebildet ist, ausgewählt aus der Gruppe, umfassend eine Nut, einen Schlitz, eine Rippe oder eine Kombination dieser Elemente.

15. Schutzvorrichtung (1) nach Anspruch 1 oder 5, dadurch gekennzeichnet, dass das erste und/oder zweite Rückstellmittel (14, 34) elastisch verformbar und ausgewählt ist aus der Gruppe, umfassend eine Schraubenfeder, ein elastisches Blatt, ein elastisch verformbares Element.

16. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass das erste Rückstellmittel (14) zwischen dem proximalen Ende des Trägers (3) und dem distalen Ende der Hülse (4) angeordnet sind.

17. Schutzvorrichtung (1) nach Anspruch 6, dadurch gekennzeichnet, dass die Hülse (4) bzw. der Träger (3) mindestens eine Stoppwand (8) umfasst, sie sich gegenüber der Lasche (5) befindet, wenn die Vorrichtung (1) in der Schutzposition ist, wobei die Stoppwand (8) derart angeordnet ist, dass sie die radiale Biegung der Lasche (5) hin zur Achse der Schutzvorrichtung in diese Schutzposition verhindert.

18. Schutzvorrichtung (1) nach Anspruch 1, dadurch gekennzeichnet, dass der Träger (3) mit einer Injektionsnadel (2) bereitgestellt ist.

19. Injektionsvorrichtung (1), umfassend mindestens eine Injektionsnadel (2) und einen Behälter mit Produkt, das injiziert werden soll, dadurch gekennzeichnet, dass sie mindestens eine Schutzvorrichtung (1) nach mindestens einem der Ansprüche 1 bis 18 umfasst.

20. Satz, umfassend eine Schutzvorrichtung (1) nach einem der Ansprüche 1 bis 18, und Verpackung (26) für diese Vorrichtung, wobei die Verpackung einen zylindrischen Körper (27) und eine Kappe (28) umfasst, wobei der zylindrische Körper auf seiner internen Wand mit Mitteln zum Blockieren der Rotation und Translation der Vorrichtung innerhalb der Verpackung ausgestattet ist.

Revendications

1. Dispositif de protection (1) destiné à couvrir au moins partiellement l'aiguille (2) d'un dispositif d'injection, ledit dispositif de protection (1) comprenant au moins :

- un support (3) pourvu d'un moyen de fixation (9) destiné à fixer ledit dispositif de protection (1) à un dispositif d'injection,

- un manchon (4) comprenant une extrémité distale (15) destinée à venir en contact avec une surface d'injection et pourvu d'un orifice destiné à permettre le passage de ladite aiguille, ledit manchon (4) étant agencé de manière à pouvoir se déplacer axialement en translation par rapport audit support (3) depuis une première position dite position de stockage, dans laquelle l'extrémité distale dudit manchon (4) se trouve à une distance l1 dudit moyen de fixation, vers une deuxième position dite position d'injection, dans laquelle l'extrémité distale dudit manchon (4) se trouve à une distance l2 dudit moyen de fixation, et vers une troisième position dite position de protection, dans laquelle l'extrémité distale dudit manchon (4) se trouve à une distance l3 dudit moyen de fixation, lesdites distances l1 et l3 étant supérieures à ladite distance l2,

- des premiers moyens de rappel (14) pour faire repasser ledit manchon (4) au moins de sa position d'injection à sa position de protection,

- au moins un tenon (6), directement et au moins élastiquement, couplé longitudinalement audit support (3) ou audit manchon (4) et reçu dans un passage de déplacement (10) prévu respectivement dans ledit manchon (4) ou dans ledit support (3), ledit passage de déplacement (10) formant plus ou moins un U, dont les branches définissent respectivement une première section (11) prise par ledit tenon (6) lorsque ledit manchon (4) se déplace de sa position de stockage à sa position d'injection et une deuxième section (12) prise par ledit tenon (6) lorsque ledit manchon (4) passe de sa position d'injection à sa position de protection, ledit tenon (6) étant conçu pour être mobile latéralement,

- des premiers moyens de sécurité (5, 21 ; 39, 34, 35), au moins une partie de ceux-ci étant élastiquement déformables, lesdits premiers moyens de sécurité (5, 21 ; 39, 36, 34, 35) étant agencés de manière à empêcher ledit tenon (6) de repasser de ladite deuxième section (12) à ladite première section (11), caractérisé en ce que ledit dispositif de protection (1) comprend au moins :

- des moyens de guidage axial (29, 30) permettant de guider ledit manchon (4), agencés de manière à l'empêcher de pivoter axialement lorsqu'il se déplace axialement par rapport audit support (3) au moins de sa position d'injection à sa position de protection.

2. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que lesdits moyens de guidage axial (29, 30) sont agencés de manière à empêcher également ledit manchon (4) de pivoter axialement lorsqu'il se déplace axialement par rapport audit support (3) de sa position de stockage à sa position d'injection.

3. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que lesdits moyens de guidage axial (29, 30) comprennent des formes géométriques longitudinales plus ou moins complémentaires prévues respectivement sur ledit manchon (4) et sur ledit support (3) et agencées en vis-à-vis pour coopérer.

4. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que lesdites première et deuxième sections (11, 12) dudit passage de déplacement (10) sont reliées entre elles par une première région rétrécie (21, 36) définie par une languette flexible (39) définissant au moins partiellement lesdits premiers moyens de sécurité.

5. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que ledit tenon (6) est poussé latéralement depuis ladite première section vers ladite deuxième section par des deuxièmes moyens de rappel (34) définissant au moins partiellement lesdits premiers moyens de sécurité.

6. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que ledit support (3) ou, respectivement, ledit manchon (4) comprend au moins une patte (5) apte à dévier tangentiellement et portant ledit tenon (6).

7. Dispositif de protection (1) selon la revendication 6, caractérisé en ce que ladite patte est agencée de façon à dévier tangentiellement de manière élastiquement déformable entre une position normale et au moins une position déviée contrainte, ladite patte (5) définissant au moins partiellement lesdits premiers moyens de sécurité.

8. Dispositif de protection (1) selon la revendication 7, caractérisé en ce que ladite patte (5) se trouve dans une position normale ou, respectivement, dans une position déviée contrainte lorsque ledit tenon (6) est dans ladite première section (11), et ladite patte (5) se trouve dans la position déviée contrainte ou, respectivement, dans la position normale lorsque ledit tenon (6) est dans ladite deuxième section (12).

9. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que lesdites première et deuxième sections (11, 12) ont des longueurs différentes agencées de manière à délimiter lesdites positions de stockage et de protection de sorte que ladite distance l3 soit supérieure à ladite distance l1.

10. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que, en face dudit passage de déplacement (10) prévu sur ledit manchon (4) ou, respectivement, sur ledit support (3), ledit support (3) ou, respectivement, ledit manchon (4) comprend un passage de déviation (35) agencé de manière à guider ledit tenon (6) latéralement.

11. Dispositif de protection (1) selon la revendication 1, caractérisé en ce qu'il comprend des deuxièmes moyens de sécurité (23, 33, 37, 34, 38) agencés de manière à bloquer ledit tenon (6) lorsque ledit manchon (4) se trouve dans ladite position de protection.

12. Dispositif de protection (1) selon la revendication 11, caractérisé en ce que ladite deuxième section (12) dudit passage de déplacement (10) comprend une deuxième région rétrécie (23) définissant au moins partiellement lesdits deuxièmes moyens de sécurité.

13. Dispositif de protection (1) selon la revendication 11, caractérisé en ce que ladite deuxième section (12) dudit passage de déplacement (10) comprend au moins un gradin (24) formant un cran d'arrêt pour ledit tenon (6) lorsque ledit manchon (4) se trouve dans ladite position de protection et définissant au moins partiellement lesdits deuxièmes moyens de sécurité.

14. Dispositif de protection (1) selon la revendication 1 ou 10, caractérisé en ce que ledit passage de déplacement (10) et/ou ledit passage de déviation (35) est/sont formé(s) d'au moins un élément choisi dans le groupe comprenant une rainure, une fente, une nervure ou une combinaison de ces éléments.

15. Dispositif de protection (1) selon la revendication 1 ou 5, caractérisé en ce que lesdits premiers et/ou deuxièmes moyens de rappel (14, 34) sont élastiquement déformables et choisis dans le groupe comprenant un ressort hélicoïdal, une lame élastique, un élément élastiquement déformable.

16. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que lesdits premiers moyens de rappel (14) sont agencés entre l'extrémité proximale dudit support (3) et l'extrémité distale dudit manchon (4).

17. Dispositif de protection (1) selon la revendication 6, caractérisé en ce que ledit manchon (4) ou, respectivement, ledit support (3) comprend au moins une paroi d'arrêt (8) située en face de ladite patte (5) lorsque le dispositif (1) se trouve dans la position de protection, ladite paroi d'arrêt (8) étant agencée de manière à empêcher la déviation radiale de ladite patte (5) vers l'axe dudit dispositif de protection dans cette position de protection.

18. Dispositif de protection (1) selon la revendication 1, caractérisé en ce que ledit support (3) est pourvu d'une aiguille d'injection (2).

19. Dispositif d'injection (1) comprenant au moins une aiguille d'injection (2) et un réservoir de produit à injecter, caractérisé en ce qu'il comprend au moins un dispositif de protection (1) selon au moins l'une des revendications 1 à 18.

20. Ensemble comprenant un dispositif de protection (1) selon l'une quelconque des revendications 1 à 18 et un emballage (26) pour ce dispositif, ledit emballage comprenant un corps cylindrique (27) et un capuchon (28), ledit corps cylindrique étant équipé sur sa paroi interne de moyens pour bloquer la rotation et la translation dudit dispositif à l'intérieur dudit emballage.

Drawing